Comparative Study Between Two Doses of Palonosetron on the Prevention of Postoperative Nausea and Vomiting in Obese Patients Undergoing Breast Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- number of patients who need antiemetic rescue medication
研究概览
简要总结
BACKGROUND: Palonosetron is a second generation serotonin antagonist usually used in a fixed dose of 75 mcg for the prophylaxis of postoperative nausea and vomiting. Although there are a few trials evaluating bodyweight-adjusted doses of palonosetron, the ideal dose for obese patients has not yet been investigated. The aim of this study is to evaluate if the use of bodyweight-adjusted doses of palonosetron (1mcg / kg) is more effective than a fixed dose (75mcg) on preventing postoperative nausea and vomiting in female patients with a body mass index equal to or above 30 kg /m2 whom have undergone breast surgery METHODS: A prospective, randomized double-blind trial will be conducted at the National Cancer Institute (INCA - HCIII), in Rio de Janeiro, Brazil. Eligible patients are female aged between 18-70 years of age with an ASA physical status of one to three, with body mass index equal to or greater than 30 kg / m2, scheduled to undergo elective breast surgery. Forty patients will be randomized to receive a fix dose of 75 μg of palonosetron (group I - GI) and 40 patients will receive a bodyweight-adjusted dose of 1mcg/kg of palonosetron (group II - GII). Patients will be assessed over 3 time periods: 0-6 h, 6-26 h and 24-48 h after surgery. After discharge, all patients will be contacted by telephone at regular intervals to record the episodes of nausea and vomiting as well as analgesic and antiemetic requirements. The primary outcome measure will include the number of emetic episodes, the incidence of nausea, the need for rescue antiemetics and the analgesic requirement over 48h. The secondary outcome will be to evaluate the frequency of polymorphism of the 5-HT3 receptors and their correlation with the antiemetic effect and adverse effects.
详细描述
Prevention of nausea and vomiting after surgery is a routine throughout anesthetic-surgical procedure, since the discomfort and morbidity associated with this anesthetic complication are widely known. The serotonin antagonists are largely used for this purpose because they exhibit superior prophylactic efficacy when compared with other antiemetic drugs. Its mechanism of action is the inhibition of calcium influx caused by stimulation of serotonin 5-hydroxytryptamine type 3 receptor (5-HT3).
Palonosetron is a second generation serotonin antagonist with high affinity binding to the 5-HT3 receptor. It has a unique chemical structure and longer half-life than older 5-HT3 antagonists. It was initially approved for use in the prevention of chemotherapy induced nausea and vomiting but also proved effective in the prophylaxis of postoperative nausea and vomiting. Palonosetron is usually used in a fixed dose of 75 mcg for the prophylaxis of postoperative nausea and vomiting. Although there are a few trials evaluating bodyweight-adjusted doses of palonosetron, the ideal dose of obese patient has not yet been investigated.
Aims & Objectives: The hypothesis for this study is that the use of bodyweight-adjusted doses of palonosetron (1mcg / kg) is more effective than a fixed dose (75mcg) for preventing postoperative nausea and vomiting in female patients with a body mass index equal to or above 30 kg / m2 whom have undergone breast surgery.
Methods: A prospective, randomized double-blind trial will be conducted at the National Cancer Institute (INCA - HCIII), in Rio de Janeiro, Brazil. All patients will be provided with written informed consent form prior to study enrolment.
Using computer-generated random numbers, the patients will be assigned into one of the two treatment groups on the morning of surgery. Forty patients will be randomized to receive a fix dose of 75 μg of palonosetron (group I - fix dose group) and another forty patients will receive a bodyweight-adjusted dose of 1mcg/kg of palonosetron (group II - bodyweight-adjusted group). Each study drug will be mixed with saline to a total volume of 10 ml in an unlabelled syringe and will be intravenously administered just prior to induction of anesthesia. All patients, surgeons, anesthesiologists involved in the study will be blinded to group allocation to maintain the double-blind conditions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •aged 18-70 years
- •ASA physical status of one to three
- •body mass index equal to or greater than 30 kg / m2
- •scheduled to undergo elective breast surgery
排除标准
- •patients who had received chemotherapy within 4 weeks,
- •patients who have undergone emergency surgery,
- •history of vomiting within 24 hours;
- •hypersensitivity to other 5-HTantagonists,
- •patients who received any antiemetic, corticosteroid, or other drug with antiemetic effect,
- •history of alcoholism.
研究组 & 干预措施
Fixed Dose Palonosetron group
patient will receive a fix dose of 75 μg of palonosetron
干预措施: palonosetron (Drug)
Bodyweight-adjusted Dose Palonosetron
patient will receive a bodyweight-adjusted dose of 1mcg/kg of palonosetron
干预措施: palonosetron (Drug)
结局指标
主要结局
number of patients who need antiemetic rescue medication
时间窗: hour 48 after surgery
Compare need of antiemetic rescue medication during the periods of 48 hours postoperatively
episodes of nausea and vomiting
时间窗: hour 48 after surgery
To determine the frequency of individual episodes of nausea and vomiting in the periods of 48 hours postoperatively
complete antiemetic response
时间窗: hour 48 after surgery
Determine the number of patients who had complete antiemetic response (absence of nausea, vomiting and need for rescue medication)
次要结局
- polymorphism of the 5-HT3 receptors(6 months)
研究者
Nathalia Ferreira
Anesthesiologist. MSc student of Department of Anesthesiology of Federal University of Rio de Janeiro, Brazil.
Instituto Nacional de Cancer, Brazil